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Autonomic Nervous System (ANS) and Renal Function in Immunoglobin A (IgA) Nephropathy

Primary Purpose

IGA Glomerulonephritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Holter
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for IGA Glomerulonephritis focused on measuring IGA Glomerulonephritis, Autonomic nervous system, ANS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of IgNA biopsy-proven free, informed, express and written

Exclusion Criteria:

  • IgNA secondary to Henoch-Schonlein purpura (HSP) or Systemic Lupus Erythematosus or alcoholic cirrhosis
  • current kidney transplantation
  • Hypertension treated or not,
  • Diseases interfering with ANS analysis: cardiac arrhythmia, beta-blocker therapy
  • diabetes

Sites / Locations

  • CHU Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

IgAN with glomerular filtration rate (GFR) >90 ml/min/1.73 m2

IgAN with GFR 60-89 ml/min/1.73 m2

IgAN with GFR 30-59 ml/min/1.73 m2

IgAN with GFR 15-29 ml/min/1.73 m2

IgAN with GFR < 15ml/min/1.73 m2

Arm Description

Measure of ANS by holter device in IgAN patients with glomerular filtration rate (GFR) >90 ml/min/1.73 m2

Measure of ANS by holter device in IgAN patients with GFR 60-89 ml/min/1.73 m2

Measure of ANS by holter device in IgAN patients with GFR 30-59 ml/min/1.73 m2

Measure of ANS by holter device in IgAN patients with GFR 15-29 ml/min/1.73 m2

Measure of ANS by holter device in IgAN patients with GFR < 15ml/min/1.73 m2.

Outcomes

Primary Outcome Measures

Standard deviation of all R-R intervals (SDNN)
Comparison of Standard deviation of all R-R intervals (SDNN) between GFR category of IgNA

Secondary Outcome Measures

Full Information

First Posted
August 18, 2015
Last Updated
August 18, 2015
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02527902
Brief Title
Autonomic Nervous System (ANS) and Renal Function in Immunoglobin A (IgA) Nephropathy
Official Title
Autonomic Nervous System (ANS) Analysis According to Different Renal Function Stage in Immunoglobin A (IgA) Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The estimation of the cardiovascular risk in the general population must take into account small renal disturbances, as the microalbuminuria. Conversely certain parameters of the cardiovascular risk influence the evolution of renal diseases, for example the arterial high blood pressure. The measure of the activity of the autonomous nervous system, and especially the quantification of its variability, is a means to estimate the cardiovascular risk. The investigators formulate the hypothesis that the variability of the autonomous nervous system is an additional clinical element for the evaluation of the evolutionary risk of renal diseases. The aim of this study is to compare the variability of the autonomous nervous system during the various evolutionary stages of the renal disease. The renal disease studied will be IgA nephropathy (IgNA). IgNA is a histologically defined glomerulonephritis (rela biopsy) by the presence of deposits immunoglobulin A (IgA) in the renal mesangium (at list 1+) by immunofluorescence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IGA Glomerulonephritis
Keywords
IGA Glomerulonephritis, Autonomic nervous system, ANS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IgAN with glomerular filtration rate (GFR) >90 ml/min/1.73 m2
Arm Type
Experimental
Arm Description
Measure of ANS by holter device in IgAN patients with glomerular filtration rate (GFR) >90 ml/min/1.73 m2
Arm Title
IgAN with GFR 60-89 ml/min/1.73 m2
Arm Type
Experimental
Arm Description
Measure of ANS by holter device in IgAN patients with GFR 60-89 ml/min/1.73 m2
Arm Title
IgAN with GFR 30-59 ml/min/1.73 m2
Arm Type
Experimental
Arm Description
Measure of ANS by holter device in IgAN patients with GFR 30-59 ml/min/1.73 m2
Arm Title
IgAN with GFR 15-29 ml/min/1.73 m2
Arm Type
Experimental
Arm Description
Measure of ANS by holter device in IgAN patients with GFR 15-29 ml/min/1.73 m2
Arm Title
IgAN with GFR < 15ml/min/1.73 m2
Arm Type
Experimental
Arm Description
Measure of ANS by holter device in IgAN patients with GFR < 15ml/min/1.73 m2.
Intervention Type
Device
Intervention Name(s)
Holter
Intervention Description
measure of ANS in IgAN patients
Primary Outcome Measure Information:
Title
Standard deviation of all R-R intervals (SDNN)
Description
Comparison of Standard deviation of all R-R intervals (SDNN) between GFR category of IgNA
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of IgNA biopsy-proven free, informed, express and written Exclusion Criteria: IgNA secondary to Henoch-Schonlein purpura (HSP) or Systemic Lupus Erythematosus or alcoholic cirrhosis current kidney transplantation Hypertension treated or not, Diseases interfering with ANS analysis: cardiac arrhythmia, beta-blocker therapy diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Alamartine, PhD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

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Autonomic Nervous System (ANS) and Renal Function in Immunoglobin A (IgA) Nephropathy

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